GORE EXCLUDER AAA Endoprosthesis PXC201000Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132610037), received between Jul 6, 2018 and Apr 1, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2010, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. TWO CONTRALATERAL LEG COMPONENTS (BOTH PXC181000) WERE IMPLANTED BILATERALLY, AND A CONTRALATERAL COMPONENT (PXC201000) WAS ADDED TO EXTEND THE RIGHT LEG. THE SPECIFIC DEVICE SERIAL NUMBER IMPLANTED AT END OF THE LEFT LEG COULD NOT BE DETERMINED. ON AN UNKNOWN DATE, TYPE IB ENDOLEAKS WERE OBSERVED IN BOTH LEGS. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. REPORTEDLY, AT THE TIME OF THE REINTERVENTION, THE RIGHT INTERNAL ILIAC ARTERY WAS FOUND TO BE OCCLUDED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. BOTH LEGS WERE EXTENDED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES INTO THE EXTERNAL ILIAC ARTERIES. THE ENDOLEAKS WERE RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24760679 ↗
• InjuryJan 7, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK-IPSILATERAL LEG) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT). ON (B)(6) 2025, THE PATIENT REQUIRED ENDOVASCULAR REINTERVENTION TO ADDRESS BOTH A TYPE 1A AND TYPE 1B ENDOLEAK CONTRIBUTING TO ANEURYSM ENLARGEMENT, WITH THE ANEURYSM SAC MEASURING 10CM AT THE TIME OF REINTERVENTION. THE PROCEDURE INCLUDED EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY, THEN DISTAL EXTENSION OF THE LEFT LIMB WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) INTO THE LEFT EXTERNAL ILIAC ARTERY IN ORDER TO TREAT THE TYPE 1B ENDOLEAK, AND PLACEMENT OF ENDO ANCHORS AT THE PROXIMAL END OF THE TRUNK TO RESOLVE THE TYPE 1A ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAKS WERE ATTRIBUTED TO DEGENERATION OF THE ARTERIES DISTAL TO THE PREVIOUSLY IMPLANTED GRAFTS. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 23991809 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR COMPONENTS WERE DEPLOYED: ONE TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED AS BOTH COMMON ILIAC ARTERIES HAD BECOME ANEURYSMAL. A TOTAL OF SEVEN NEW COMPONENTS WERE PLACED: ONE CONTRALATERAL LEG, TWO ILIAC BRANCH COMPONENTS, TWO INTERNAL ILIAC COMPONENTS, AND TWO VBX. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion

  MAUDE report 23376900 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR COMPONENTS WERE DEPLOYED: ONE TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED AS BOTH COMMON ILIAC ARTERIES HAD BECOME ANEURYSMAL. A TOTAL OF SEVEN NEW COMPONENTS WERE PLACED: ONE CONTRALATERAL LEG, TWO ILIAC BRANCH COMPONENTS, TWO INTERNAL ILIAC COMPONENTS, AND TWO VBX. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion

  MAUDE report 23376897 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN INFRARENAL AORTIC ANEURYSM, TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT FOLLOW UP IMAGES (MODALITY AND DATE IS UNKNOWN) REVEALED A DISTAL TYPE I ENDOLEAK ON THE (PXC201000/9641391 DEVICE). THE ANEURYSM HAD LOST SEAL IN THE ILIAC ARTERY AND THERE WAS ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN). THE ROOT CAUSE FOR THE ENDOLEAK IS UNKNOWN. THE PHYSICIAN REINTERVENED ON (B)(6) 2025, AND IMPLANTED A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23357347 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. AT AN UNKNOWN DATE, THE LEFT COMMON ILIAC ARTERY, AT THE SITE WHERE THE DISTAL END OF A CONTRALATERAL LEG ENDOPROSTHESIS HAD BEEN IMPLANTED, WAS FOUND TO BE DILATED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG ENDOPROSTHESIS) WAS IMPLANTED TO EXTEND THE INITIALLY IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS TO THE LEFT EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT. THE PHYSICIAN STATED THAT THE INITIALLY IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS WAS UNDERSIZED BECAUSE THE DIAMETER OF THE LARGEST COMMERCIALLY AVAILABLE DEVICE AT THAT TIME WAS 20 MM.

  Patient problems: Aneurysm

  MAUDE report 22713037 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 21913025 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. 1X TRUNK IPSILATERAL LEG AND TOTAL 4X CONTRALATERAL LEGS WERE IMPLANTED, EXTENDING TO BOTH COMMON ILIAC ARTERIES. ON AN UNKNOWN DATE, EXPANSION OF BOTH COMMON ILIAC ARTERIES WAS OBSERVED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. BOTH INTERNAL ILIAC ARTERIES WERE COIL-EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE PLACED IN EACH EXTERNAL ILIAC ARTERIES. FURTHERMORE, A BIRD-BEAK WAS OBSERVED AT THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG. ALTHOUGH NO ENDOLEAK WAS OBSERVED, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY AS A PREVENTIVE MEASURE. THE PHYSICIAN¿S COMMENT: ¿AS WE DO NOT HAVE SURGICAL RECORDS, IT IS UNCLEAR WHETHER THE INITIAL PLACEMENT OF STENT GRAFTS WAS SUBOPTIMAL OR IF THERE WAS AN ERROR IN SIZE SELECTION. ALTHOUGH MORE THAN 16 YEARS HAD PASSED SINCE THE INITIAL PLACEMENT, NO DAMAGE OR DETERIORATION OF THE DEVICE WAS OBSERVED.¿

  Patient problems: Aneurysm expansion

  MAUDE report 21315775 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, THE RIGHT COMMON ILIAC ARTERY ANEURYSM ENLARGEMENT WAS OBSERVED. ON (B)(6) 2024, CONSIDERING A RISK OF OCCURRENCE OF TYPE IB ENDOLEAK, A REINTERVENTION WAS PERFORMED. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES WERE IMPLANTED IN THE RIGHT ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20607896 ↗
• InjuryJul 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES (2 CONTRALATERAL LEGS, 1 AORTIC EXTENDER, AND 1 TRUNK-IPSILATERAL LEG). ON (B)(6) 2024, DURING A FOLLOW UP CT SCAN, THE PHYSICIAN CONTACTED THE FSA AND REPORTED THAT THE PATIENT HAD BILATERAL TYPE 1B ENDOLEAKS. THEY PLAN TO IMPLANT ONE IBE MOST LIKELY ON THE LEFT LIMB AND THEN POSSIBLY ONE ON THE RIGHT AS WELL IN A FEW WEEKS.

  Patient problems: Clinical Endoleak

  MAUDE report 19688503 ↗
• InjuryJul 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESES (2 CONTRALATERAL LEGS, 1 AORTIC EXTENDER, AND 1 TRUNK-IPSILATERAL LEG). ON (B)(6) 2024, DURING A FOLLOW UP CT SCAN, THE PHYSICIAN CONTACTED THE FSA AND REPORTED THAT THE PATIENT HAD BILATERAL TYPE 1B ENDOLEAKS. THEY PLAN TO IMPLANT ONE IBE MOST LIKELY ON THE LEFT LIMB AND THEN POSSIBLY ONE ON THE RIGHT AS WELL IN A FEW WEEKS.

  Patient problems: Clinical Endoleak

  MAUDE report 19688498 ↗
• InjuryMar 5, 2024Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS (EXCLUDER). ON UNKNOWN DATE, WHEN A CT EXAM WAS PERFORMED, THE DISTAL END OF AN EXCLUDER DEVICE THAT HAD BEEN IMPLANTED TO THE LEFT COMMON ILIAC ARTERY WAS FOUND TO HAVE MIGRATED PROXIMALLY (>10MM). THE DISTAL SEALING LENGTH OF THE DEVICE HAD BEEN SHORTENED, THEREFORE, A REINTERVENTION WAS PLANNED FOR TREATMENT. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED, AND TWO ADDITIONAL STENT GRAFTS WERE ADDED TO THE DISTAL END OF PREVIOUSLY IMPLANTED DEVICE TOWARDS THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18843138 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6)2013, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A LEFT LEG DEVICE WAS IMPLANTED TO THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE, (B)(6) 2023, A COMPUTED TOMOGRAPHY REVEALED AN ENLARGED ANEURYSM DIAMETER AND OCCLUSION OF THE LEFT EXTERNAL ILIAC ARTERY. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED FOR THE ENDOLEAK. A DILATION OF THE LEFT COMMON ILIAC ARTERY WAS OBSERVED. TWO GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DEVICES WERE ADDITIONALLY IMPLANTED FROM THE BIFURCATION TO THE LEFT INTERNAL ILIAC ARTERY. THE LEFT EXTERNAL ILIAC ARTERY REMAINED OCCLUDED, BUT NO FURTHER TREATMENT WAS GIVEN. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTEDLY STATED THAT THE ENLARGED ANEURYSM DIAMETER WAS CAUSED BY THE DISTAL TYPE I ENDOLEAK. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE OCCLUSION.

  Patient problems: Clinical Endoleak; Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 18080176 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2012, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH EXPANSION OF THE LEFT-SIDED ILIAC ANEURYSM DUE TO DISTAL MIGRATION OF THE TRUNK IPSILATERAL LEG. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH COIL EMBOLIZATION OF LEFT ILIAC INTERNAL BRANCHES AND IMPLANTATION OF A STENT GRAFT.

  Patient problems: Aneurysm; Aneurysm expansion

  MAUDE report 17869038 ↗
• InjuryMay 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM AND BILATERAL COMMON ILIAC ARTERIES WAS OBSERVED, AND DISTAL TYPE I ENDOLEAK ON BOTH SIDES WAS SUSPECTED. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHEREBY ALL COMPONENTS WERE REMOVED, AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL EVENT INFORMATION WAS REQUESTED, BUT NONE WAS PROVIDED.

  Patient problems: Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14359198 ↗
• InjuryMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2011, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A NON-GORE MANUFACTURED STENT GRAFT AS A MAIN BODY, AND A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT IMPLANTED DISTALLY ON EACH SIDE. ON UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY REVEALED BILATERAL DISTAL TYPE I ENDOLEAKS. ADDITIONAL EVENT INFORMATION, INCLUDING THE CAUSE OF THE ENDOLEAKS, WAS REQUESTED BUT NOT AVAILABLE. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED TO TREAT BOTH TYPE I ENDOLEAKS. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL GORE® EXCLUDER® COMPONENT WAS IMPLANTED TO EXTEND THE STENT GRAFT SYSTEM DISTALLY ON THE RIGHT SIDE. AN INTRA-OPERATIVE ANGIOGRAPH AT THE LEFT LEG REVEALED NO DISTAL TYPE I ENDOLEAK, BUT THE PHYSICIAN REPORTEDLY ELECTED TO IMPLANT AN ADDITIONAL GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14340246 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK WAS SUSPECTED DUE TO RIGHT COMMON ILIAC ARTERY ENLARGEMENT DURING THE FOLLOW UP EXAM. ON (B)(6) 2021, A REINTERVENTION TOOK PLACE. AN ADDITIONAL STENT GRAFT WAS DEPLOYED AFTER THE RIGHT INTERNAL ILIAC WAS INTENTIONALLY OCCLUDED. THE STENT GRAFT WAS PLACED AT THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12307752 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE , AT A FOLLOW UP EXAMINATION, ANEURYSM ENLARGEMENT WAS DETECTED IN THE BILATERAL COMMON ILIAC ARTERIES. ON (B)(6) 2021, REINTERVENTION WAS PERFORMED. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND STENT GRAFTS WERE IMPLANTED BOTH INTO THE RIGHT EXTERNAL ILIAC ARTERY AND LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THE BOTH COMMON ILIAC ARTERIES HAD TENDENCY OF ANEURYSMS AT THE INDEX PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11569851 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, FILMS WERE READ BY THE GORE FIELD SALES ASSOCIATE THAT REVEALED THE CONTRALATERAL LEG COMPONENT IN THE RIGHT COMMON ILIAC ARTERY HAD NO DEVICE APPOSITION TO THE VESSEL WALL. ON (B)(6) 2020, A REINTERVENTION OCCURRED WHEREBY ADDITIONAL COMPONENTS WERE IMPLANTED TO TREAT THE LACK OF CIRCUMFERENTIAL DEVICE APPOSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788679 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, FILMS WERE READ BY THE GORE FIELD SALES ASSOCIATE THAT REVEALED THE CONTRALATERAL LEG COMPONENT IN THE LEFT COMMON ILIAC ARTERY WAS NOW "FLOATING IN THE ANEURYSM SAC. ON (B)(6) 2020, A REINTERVENTION OCCURRED WHEREBY ADDITIONAL COMPONENTS WERE IMPLANTED TO TREAT THE LACK OF CIRCUMFERENTIAL DEVICE APPOSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788676 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) INDICATED APPROXIMATELY 3CM GROWTH OF THE LEFT COMMON ILIAC ARTERY (LCIA) DISTAL TO THE IMPLANTED DEVICE IN THE LCIA ON THE CONTRALATERAL SIDE. SEAL WAS STILL EVIDENT IN THE PROXIMAL LCIA. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND THE LEFT INTERNAL ILIAC ARTERY WAS COILED AND TWO ADDITIONAL GORE® CONTRALATERAL LEG COMPONENTS WERE IMPLANTED TO BRIDGE AND EXTEND COVERAGE FROM THE LEVEL OF THE FLOW DIVIDER DOWN TO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ISSUES AND IS DOING WELL.

  Patient problems: Aneurysm

  MAUDE report 8613364 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC AND RIGHT COMMON ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS REPORTED TO HAVE BEEN INTENTIONALLY COVERED BY THE DEVICE, FOLLOWED BY COIL EMBOLIZATION. THE PATIENT'S LEFT SIDE WAS REPORTED TO BE "SHAGGY" BUT NOT ANEURYSMAL. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SHOWED ANEURYSMAL DISEASE PROGRESSION WITHIN THE LEFT COMMON ILIAC ARTERY. NO ENDOLEAK OR LOSS OF DISTAL APPOSITION WAS REPORTED. ON (B)(6) 2019, THE PATIENT UNDERWENT RE-INTERVENTION WHEREIN THE LEFT SIDE WAS TREATED ENDOVASCULARLY AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS WERE IMPLANTED TO EXTEND COVERAGE OF THE LEFT SIDE DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8550422 ↗
• InjuryApr 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012 A PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM MEASURING 57MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 A CT SHOWED THE ANEURYSM MEASURED 95MM. ON (B)(6) 2019 A RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM WAS RECOGNIZED AND A CONVERSION TO OPEN REPAIR WAS PERFORMED. TYPE II AND III ENDOLEAKS WERE REPORTED. THE TYPE II ENDOLEAK FROM A LUMBAR ARTERY WAS ADDRESSED BY SUTURE CLOSURE USING A DOUBLE NEEDLE 3-0 PROLENE SUTURE, 2.2. THE TYPE III ENDOLEAK WAS ADDRESSED WITH TWO CONTRALATERAL LEG COMPONENTS. ON (B)(6) 2019 THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST, DUE TO A CARDIAC COMPLICATION FOLLOWING ANGIOPLASTY.

  Patient problems: Aneurysm

  MAUDE report 8489649 ↗
• InjuryJul 6, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS WITH A SYSTEM OF GORE EXCLUDER AAA ENDOPROSTHESES. ACCORDING TO THE REPORT, THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED, AND INTENTIONALLY COVERED BY THE IPSILATERAL LIMB OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PROCEDURE CONCLUDED WITH THE IMPLANTATION OF TWO CONTRALATERAL LEG COMPONENTS (PXC141000 AND PXC201000- MOST DISTAL) ON THE PATIENT¿S LEFT SIDE. ACCORDING TO THE REPORT, THE CONTRALATERAL LEG COMPONENT (PXC201000) WAS UNDERSIZED FOR PLACEMENT WITHIN THE PATIENT¿S 22.2 MM LEFT COMMON ILIAC ARTERY, HOWEVER AT THE TIME OF THE INITIAL IMPLANT PROCEDURE, A LARGER DEVICE WAS REPORTEDLY NOT AVAILABLE. INTRA-PROCEDURAL ANGIOGRAPHY WAS PERFORMED, A DISTAL TYPE I ENDOLEAK WAS OBSERVED ORIGINATING FROM THE MOST DISTAL CONTRALATERAL LEG COMPONENT (PXC201000). AS IT WAS DETERMINED, THE ENDOLEAK WAS NOT COMMUNICATING WITH THE ANEURYSMAL SAC, THE PHYSICIAN ELECTED NOT TO PERFORM AN ADDITIONAL PROCEDURE TO TREAT THE ENDOLEAK. FINAL ANGIOGRAPHY, SHOWED EXCLUSION OF ALL ANEURYSMS AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE. ACCORD

  Patient problems: Aneurysm

  MAUDE report 7666500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)